UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: October 23, 2014 

SUBJECT: Spirodiclofen: Tier I Review of Human Incidents 

PC Code: 124871 DP Barcode: 0422435 

Decision No.: 494556 

Petition No.: NA 

Risk Assessment Type: N A 

TXRNo.:NA 

MRIDNo.:NA 

Registration No.: NA 

Regulatory Action: NA 

Case No.: NA 

CAS No.: 148477-71-8 

40CFR:NA 

Ver.Apr.08 

Elizabeth Evans, Environmental Protection Specialist c;·_ -A ~ ~ 

Toxicology and Epidemiology Branch c; k.~ YY'VJO 

FROM: 

Health Effects Division (7509P) ....,- 0- ~- . • 

and ~{) -" 

Toxicology 

Shanna Recore, 

and 

Industrial 

Epidemiology 

Hygienist 

Branch 

~ 

Health Effect Division (7509P) 

THROUGH: David Miller, Acting Branch Chief .eJ:.1'f!5-.ll'v Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

TO: Kelly Lowe, Risk Assessor 

Risk Assessment Branch V 

Health Effects Division (7509P) 

and 

Julia Stokes, Chemical Review Manager 

Risk Management & Implementation Branch 2 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Based on the low frequency and low severity of cases involving spirodiclofen reported in both 

IDS and SENSOR-Pesticides, there does not appear to be a concern at this time that would 

warrant further investigation. The Agency will continue to monitor the incident information and 

if a concern is triggered, additional analysis will be included in the risk assessment. 

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... 

Detailed Review 

I. ACTION REQUESTED 

This review is intended to fulfill our requirement to docket summaries of incident data that were 

reported to the Agency, as well as to ensure human incident data and the Agricultural Health 

Study (AHS) are part of the problem formulation phase of registration review. Reports of 

adverse health effects allegedly due to a specific pesticide exposure (i.e., an "incident") are 

largely self-reported and therefore, generally speaking, neither exposure to a pesticide or 

reported symptom (or the connection between the two) is validated or otherwise confirmed. 

Typically, causation cannot be determined based on incident data. However, incident 

information can be an important source of feedback to the Agency: incidents of severe outcome, 

or a suggested pattern or trend among less severe incidents, can signal the Agency to further 

investigate a particular chemical or product. Observational epidemiology studies relate the risk 

of disease, e.g., cancer, and exposure to an agent such as a pesticide product in the general 

population or specific sub-groups like pesticide applicators. 

II. BACKGROUND 

Spirodiclofen is an insecticide/miticide in the tetronic acid chemical class. The mode of action is 

inhibition of lipid synthesis. It controls mites and San Jose scale in citrus, grapes, pome fruit, 

stone fruit, and tree nut crops. The method of application is ground boom. 

For this evaluation, both the OPP Incident Data System (IDS) and the Centers for Disease 

Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) 

Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were 

consulted for pesticide incident data on the active ingredient spirodiclofen (pc code: 124871). 

The purpose of the database search is to identify potential patterns in the frequency and severity 

of the health effects attributed to carboxin exposure. Spirodiclofen is not included in the AHS, 

and therefore this study does not provide information for this report. 

III. RESULTS/DISCUSSION 

a. IDS (Incident Data System) 

OPP's IDS includes reports of alleged human health incidents from various sources, including 

mandatory Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports 

from registrants, other federal and state health and environmental agencies, and individual 

consumers. Since 1992, OPP has compiled these reports in IDS. IDS contains reports from 

across the U.S. and most incidents have all relevant product information recorded. Reports 

submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in 

the report. 

IDS records incidents in one of two modules: Main IDS and Aggregate IDS: 

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o Main IDS contains incidents resulting in higher severity outcomes and provides 

more detail with regard to case specifics. This system stores incident data for 

death, major and moderate incidents, and it includes information about the 

location, date and nature of the incident. Main IDS incidents involving only one 

active ingredient (as opposed to pesticide products with multiple active 

ingredients) are considered to provide more certain information about the 

potential effects of exposure from the pesticide. 

o Aggregate IDS contains incidents resulting in less severe human incidents (minor, 

unknown, or no effects outcomes). These are reported by registrants only as 

counts in what are aggregate summaries. 

For the Main IDS, from January 1, 2009 to August 12, 2014, there were 0 incidents reported for 

the single chemical only in the database. There was 1 incident reported involving more than one 

chemical. 

In Aggregate IDS, from January 1, 2009 to August 12,2014, there were 2 incidents reported 

involving spirodiclofen in the database. These incidents were classified as minor severity. 

Overall, there are few incidents involving spirodiclofen reported to IDS. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers 11 states from 1998-2010, although reporting varies 

from state to state. Cases of pesticide-related illnesses are ascertained from a variety of sources, 

including: reports from local Poison Control Centers, state Department of Labor workers' 

compensation claims when reported by physicians, reports from State Departments of 

Agriculture, and physician reports to state Departments of Health. Although both occupational 

and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on 

occupational pesticide incidents, and is of particular value in providing that information. The 

state coordinator at each of the 11 respective state Departments of Health conducts case followup activities such as obtaining medical records to verify symptoms and severity. Using 

standardized protocol and case definitions derived from poison center reporting, the state 

SENSOR-Pesticide coordinator enters the incident information into the state-based system which 

is sent to NIOSH annually to be aggregated. 

A query of SENSOR-Pesticides from 1998-2010 identifies three cases involving spirodiclofen 

(pc code 124871); two cases involved a single active ingredient and will be analyzed for this 

memo. Both cases were low in severity and related to agricultural work. Both cases involved 

Envidor 2 SC, EPA regulation # 264-831. The label requires waterproof gloves for 

handlers/mixers/loaders; the label does not require eye protection. One case was exposed via 

splash from a tank loading accident and experienced ocular symptoms. The second case was an 

orchard worker who was drifted on while packing apples, the case description and symptoms are 

provided: 

"A 29 year-old female was packing apples in the field when a sprayer passed by in the next row. 

She felt moisture droplets on her face and smelled a chemical odor. Within 5 minutes she had 

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gastrointestinal and neurological symptoms. She reports phoning her local clinic on day of 

exposure and the next, but that she was unable to get an appointment. Her GI symptoms 

continued and became worse over the next six days. She sought medical care on sixth day at ER" 

c. Agricultural Health Study (AHS) 

The AHS is a high quality, prospective epidemiology study evaluating the link between pesticide 

use and various health outcomes including cancer. The AHS includes private and commercial 

pesticide applicators and their spouses. If there are AHS findings relevant to a particular 

pesticide going through registration review, the Agency will ensure they are considered in the 

problem formulation/scoping phase of the process and, if appropriate, fully reviewed in the risk 

assessment phase of the process. The AHS includes information on use of 80 different pesticide 

active ingredients commonly used in agriculture. Spirodiclofen is not included in the AHS, and 

therefore this study does not provide information for this report. 

IV. CONCLUSION 

Based on the low frequency and low severity of cases involving spirodiclofen reported in both 

IDS and SENSOR-Pesticides, there does not appear to be a concern at this time that would 

warrant further investigation. The Agency will continue to monitor the incident information and 

if a concern is triggered, additional analysis will be included in the risk assessment. 

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